FDA to guide device makers on marketing application

(Reuters) – The Food and Drug Administration plans to provide medical device makers feedback before they apply for marketing approval to help companies identify regulatory requirements early in the device development process.

The new program, called “Pre-Sub,” comes a day after the Congress passed the FDA User Fee Reauthorization Bill that increases fees paid by companies to the health regulator in return for more meetings.

“FDA’s early feedback on studies can facilitate the development of a quality premarket submission and help industry avoid regulatory hurdles during the review process,” said Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health (CDRH).

A similar process, called a Special Protocol Assessment, already exists for drugs and medicines, where the FDA and drugmakers meet and agree on a specific design and main goals for a clinical study.

The drugmaker receives guidance on the marketing application for the drug, reducing chances of rejection after review.